Acne |
Pimples; Zits |
Clinical Trial: Infrared Non-Cutting Laser Therapy for Acne
This study is currently recruiting patients.
|
Purpose
The purpose of this research project is to study the effect of non-ablative (non-cutting) laser therapy, a technique that uses laser energy to try to improve the appearance of the skin. In this study, we are interested in learning how well such a laser works to improve the symptoms of acne. The laser used in this particular study will be the CoolTouch II® laser, manufactured by ICN Photonics, Inc., and has not been FDA-approved for the treatment of acne.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Acne Vulgaris | Device: CoolTouch II laser | Phase II Phase III |
MedlinePlus related topics: Acne
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: CoolTouch Non-ablative Laser Therapy for Acne Vulgaris
Secondary Outcomes: Sebum production will be measured with Sebutape; Photographic evaluations
Expected Total Enrollment: 50
Study start: February 2003; Expected completion: June 2006
Last follow-up: December 2005; Data entry closure: March 2006
The purpose of this research project is to study the effect of non-ablative (non-cutting) laser therapy, a technique that uses laser energy to try to improve the appearance of skin. This type of laser treatment creates changes in a layer of the skin called the dermis without causing an open wound in the skin. It is not yet clear how much improvement can be seen with these treatments or exactly how the skin’s response causes these improvements. In this study, we are interested in learning how well such a laser works to improve the symptoms of acne. The laser used in this particular study will be the CoolTouch II® laser, manufactured by ICN Photonics, Inc., and has not been FDA-approved for the treatment of acne.
Eligibility
Ages Eligible for Study: 13 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Age 13 years or older of either gender and of any racial/ethnic group.
- Subjects must have clinically evident acne vulgaris of the facial skin.
- Subjects must understand and sign the informed consent prior to participation.
- Subjects must be in generally good health.
- Subjects must be able and willing to comply with the requirements of the protocol.
Exclusion Criteria:
- Oral retinoid (Accutane) use within 1 year of entry into the study.
- Systemic acne therapies (oral antibiotics) within 4 weeks of entry into the study.
- Topical acne therapies (retinoids, antibiotics) within 2 weeks of entry into the study.
- Microdermabrasion or superficial chemical peels at the sites to be treated within 3 months of entry into the study.
- Subjects with a history of dermabrasion or laser resurfacing at the sites to be treated.
- Use of topical lipid absorbing substances (Clinac AC) within 2 weeks of entry into the study.
- Non-compliant subjects.
- Subjects with a significant medical history or concurrent illness/condition which the investigator(s) feel is not safe for study participation.
- Subjects using alcohol-based topical solutions or “exfolliating” agents within 2 weeks of entry into the study.
- Subjects with a history of very frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections.
- History of keloid scar formation for subjects undergoing biopsies.
- Pregnant or nursing females.
Location and Contact Information
Michigan
University of Michigan Dermatology Department, Ann Arbor, Michigan, 48109-0314, United States; Recruiting
Jeffrey S Orringer, MD 734- 936-4190 jorringe@umich.edu
Jeffrey S Orringer, MD, Principal Investigator
More Information
Record last reviewed: May 2005
Last Updated: May 13, 2005
Record first received: May 11, 2005
ClinicalTrials.gov Identifier: NCT00110643
Health Authority: United States: Institutional Review Board (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-05-17
Source: ClinicalTrials.gov
Cache Date: May 18, 2005
Resources
- Accutane Capsules (Isotretinoin) (Center for Drug Evaluation and Research)
- Acné (American Academy of Dermatology)

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